Explore: Biological Licence Application (BLA) | Clinical Trial Application Dossier | Narratives | New Drug Application (NDA) | Pregnancy Prevention Plan (or Programme, PPP) | Product Information (PI) | Statistical Analysis Plan (SAP) | Summary of Product Characteristics (SmPC) | United States Prescribing Information (USPI)
Product Information (PI)
- PI is an intrinsic part of the application for marketing authorisation of a new drug or medicine. In the European Union it includes the Summary of Product Characteristics (SmPC) and the Package Leaflet (PL); it names the authorization holder and sets out the conditions of the authorization. The equivalent of the SmPC in the United States is the United States Prescribing Information (USPI).
- Trilogy understands the intent and needs of PI, and is able to help your teams produce a document that is a consistent reflection of the data available from your clinical programme and submission dossier.